Psychopharmacologic Drugs Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee February 2, 2004 Postmarketing spontaneous reports of suicidal events associated with pediatric use of antidepressant drugs

Limitations of Data Sources

–rarity of completed suicide as an outcome

–difficulty in identifying individuals with outcome of completed suicide

–difficulty of classifying outcomes of non-fatal suicidal behavior

–difficulty obtaining data on drug exposure

–lack of suitable control/comparison groups

–confounding by indication

–privacy restrictions